US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis

NCT02578134 | Withdrawn DMC

• 1 other identifier: URJC 09-2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.

Conditions

Plantar Heel Pain, Plantar Fasciosis

Outcome Measures

Primary Outcomes (1)

• Changes in disability before and after the intervention

  The Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain

  Baseline, one week after the last session, and 3 months after the last session

Secondary Outcomes (2)

• Changes in pain intensity before and after the intervention

  Baseline, one week after the last session, and 3 months after the last session

• Changes in thickness of the plantar fascia

  Baseline, one week after the last session, and 3 months after the last session

Study Arms (2)

US-guided percutaneous electrolysis

EXPERIMENTAL

Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day.

Other: US-guided percutaneous electrolysis

Sham US-guided percutaneous electrolysis

SHAM COMPARATOR

Patients will receive one weekly session for 5 weeks for 5 weeks of sham US-guided percutaneous electrolysis. In this case, the acupuncture needle will be inserted in the soft tissue, in this case the plantar fascia insertion without the application of the galvanic electrical current. In addition, patients will be asked for conducting a best-evidence low-load exercise programs for the intrinsic foot musculature. The exercise program will be asked to be performed on an individual basis twice every day.

Other: Sham US-guided percutaneous electrolysis

Interventions

US-guided percutaneous electrolysis OTHER

US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the symptomatic insertion of the plantar fascia

US-guided percutaneous electrolysis

Sham US-guided percutaneous electrolysis OTHER

The acupuncture needle will be inserted into the symptomatic plantar fascia but no galvanic electrical current will be applied, the equipment will be turn off. Patients will be blinded to the application of galvanic electrical current.

Sham US-guided percutaneous electrolysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing;
• plantar heel pain which increases in the morning with the first steps after waking up;
• symptoms decreasing with slight levels of activity, such as walking.

You may not qualify if:

• prior surgery in the lower extremity;
• diagnosis of fibromyalgia syndrome;
• previous physical therapy interventions for the foot region in the previous 6 months
• lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28921, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Division

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

ES (1)